Successful market access in Germany starts with strong and reliable dossier development
Since AMNOG, the legal framework for market access in Germany, was introduced in 2011, Cencora has supported pharmaceutical and biotechnology companies through the German market access process. Our Germany-based team of more than 35 experienced professionals, including native English speakers, combines strategic market access expertise with in-depth knowledge of AMNOG dossier development. Dedicated in-house capabilities in AMNOG statistics and real-world evidence (RWE) allow us to address both strategic and methodological challenges throughout the process.
We treat AMNOG as a process that begins long before dossier submission and continues beyond the assessment by the Federal Joint Committee (G-BA). That perspective lets us support clients along the entire market access pathway, from evidence generation and dossier strategy to reimbursement and pricing discussions. Together with our partner Dierks+Company, we can also provide support through the price negotiation phase.
The evolving European health technology assessment (HTA) framework is creating new requirements for evidence planning and market access strategy. Our local experts, backed by Cencora's global capabilities, support Joint Clinical Assessments (JCA), Joint Scientific Consultations (JSC), PICO and evidence-planning strategies, integration of EU HTA requirements into clinical development programs, national implementation of JCA outcomes, and pipeline assessments.
We treat AMNOG as a process that begins long before dossier submission and continues beyond the assessment by the Federal Joint Committee (G-BA). That perspective lets us support clients along the entire market access pathway, from evidence generation and dossier strategy to reimbursement and pricing discussions. Together with our partner Dierks+Company, we can also provide support through the price negotiation phase.
The evolving European health technology assessment (HTA) framework is creating new requirements for evidence planning and market access strategy. Our local experts, backed by Cencora's global capabilities, support Joint Clinical Assessments (JCA), Joint Scientific Consultations (JSC), PICO and evidence-planning strategies, integration of EU HTA requirements into clinical development programs, national implementation of JCA outcomes, and pipeline assessments.
Our services
Our support is tailored to the specific needs of each product and development stage and includes:
AMNOG, EU HTA, and JSC strategy
Positioning for German and European pathways, including JCA planning, PICO development, and integration of EU HTA requirements into clinical programs.
G-BA advice meetings
Strategic consulting and document development for G-BA Advice Meetings. Support and strategical guidance on simulation and oral hearing with the G-BA.
AMNOG Dossier medical writing
Medical writing of full AMNOG dossiers and written statements, drafted by experienced medical writers with strong biomedical educational background always keeping clients‘ needs in mind.
AMNOG statistics and analyses
In-house AMNOG statistics and clinical data analyses, so methodological questions are answered by the same team that built your dossier.
Real-world evidence generation
RWE generation based on key local data sources and primary data collections or surveys designed to fill identified evidence gaps.
Pricing and reimbursement strategy
Stress testing of your value proposition, plus hands-on support through payer discussions and the price negotiation phase.
Beyond AMNOG: EU HTA and JCA
The evolving European HTA framework is creating new requirements for evidence planning and market access strategies. Our local experts, backed by Cencora's global capabilities, support clients in addressing these challenges.
We provide support for:
- Joint Clinical Assessments (JCA)
- Joint Scientific Consultations (JSC)
- PICO and evidence-planning strategies
- Integration of EU HTA requirements into clinical development programs
- National implementation of JCA outcomes
- Pipeline assessments
- Conference posters and papers as well as other value communication documents
With a team of more than 35 experienced Germany-based professionals (including English native speakers) and the backing of a global organization, we help companies navigate both German and European market access requirements with confidence.
Need more information about market access in Germany?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.